ZEP ROUND ONE AB- chloroxylenol liquid

ZEP ROUND ONE AB by

Drug Labeling and Warnings

ZEP ROUND ONE AB by is a Otc medication manufactured, distributed, or labeled by Zep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Chloroxylenol 0.4%

PURPOSE

Antiseptic Handwash

Uses

Hand washing to decrease bacteria on skin

WARNINGS

For external use only.

DO NOT USE

Do not use in or around the eyes.

When using this product

• If eye contact occurs, rinse promptly and thoroughly with water.
• Do not swallow.
• If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.

STOP USE

Stop use and ask a doctor if skin irritation or redness persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children except under adult supervision.

Directions

• Wet hands with water.
• Place hands under dispenser and apply liquid soap.
• Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.
• Rinse hands thoroughly and dry.

OTHER SAFETY INFORMATION

• Do not freeze.
• Dispose in accordance with all applicable federal, state and local regulations.

INACTIVE INGREDIENT

Water, Sodium C14-16 Olefin Sulfonate, Pumice, Cocamidopropyl Hydroxysultaine, Stearic Acid, Methacrylic Acid Copolymer, Attapulgite, C11-13 Pareth-6, PEG-75 Lanolin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Glutaral, Titanium Dioxide, Palmitostearic Acid, Orange 7, Yellow 5

Questions or comments?

Call 1-877-I-BUY-ZEP (1-877-428-9937)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZEP ROUND ONE AB 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66949-309
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
PUMICE (UNII: NT5NN5KL16)
ATTAPULGITE (UNII: U6V729APAM)
PEG-75 LANOLIN (UNII: 09179OX7TB)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
GLUTARAL (UNII: T3C89M417N)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
DIPOTASSIUM 4',5'-DIBROMOFLUORESCEIN (UNII: 3T0760MA5A)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
C11-13 PARETH-6 (UNII: G892LZ1790)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66949-309-24	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/19/2017

Labeler - Zep Inc. (030471374)

Establishment
Name	Address	ID/FEI	Business Operations
Zep Inc.		112125310	manufacture(66949-309)